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- PMLiVE

Pradaxa

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FDA panel backs CV claims for Novo Nordisk’s Victoza

LEADER trial shows the diabetes treatment reduces risk of cardiovascular death by 13%

Bayer symbol

Bayer wins FDA approval for MS electronic autoinjector and app

US regulator gives green light to Betaconnect and myBETA app

Eli Lilly HQ

FDA fast-tracks Pfizer and Lilly’s tanezumab

The novel pain drug treats osteoarthritis and chronic low back pain

- PMLiVE

Novo Nordisk’s long-acting haemophilia B drug cleared by FDA

US approval sets up marketing battle with Bioverativ and CSL Behring

Novartis building

Novartis’ Zykadia claims US approval for first-line lung cancer

The Swiss pharma giant’s drug also receives CHMP positive opinion

- PMLiVE

FDA panel backs Puma’s breast cancer drug, with reservations

Side effects concerns could see medicines limited

- PMLiVE

Keytruda is first FDA-approved drug for molecular indication

Indicates a significant development in the shift towards personalised medicine

Sanofi reception

Sanofi/Regeneron’s Sarilumab cleared by FDA on second attempt

IL-6 inhibitor to treat adult RA patients

- PMLiVE

Merck and Pfizer claim second FDA nod for cancer drug Bavencio

Analysts predict it will bring in sales of around $600m by 2020

- PMLiVE

Gottlieb heading to FDA after clearing Senate vote

Trump’s favoured candidate received bipartisan support despite criticism

- PMLiVE

FDA clears new ALS drug Radicava ahead of schedule

MT Pharma’s medicine will soon offer US patients an alternative to Sanofi’s Rilutek

AstraZeneca AZ

AZ gets first OK for PD-L1 inhibitor durvalumab

US regulators also approve Roche’s Ventana

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